Lawyer makes his case for treatment
“Boston Legal” “Juiced” episode, ABC, Dec. 1
The premise
Denny Crane (William Shatner) is undergoing a PET scan. The colors and images show that his brain activity is diminished in certain areas. While he is on the scanner, his doctors also test his ability to count backward from 100 by 7s and find that this ability has deteriorated.
They conclude from the scan and tests that his Alzheimer’s disease has progressed to Stage 3 or 4, signifying mild to moderate memory decline. New memories are most difficult, older memories less so. Crane has also become socially withdrawn.
He learns of an experimental drug (known as Dimebon) studied to treat Alzheimer’s disease in Russia and tries to get it on humane grounds, even though it isn’t approved by the Food and Drug Administration.
There are ongoing Stage 3 FDA trials, but Crane is told that “Pfizer bought the rights” and it won’t be available for public use for at least three years, when the clinical trials are likely to be completed.
His battle to receive this drug goes all the way to the U.S. Supreme Court.
Crane is frequently disoriented during this period and experiences delusions that he is back in the past with his young daughter. His doctor tells him he may live for years in this condition.
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The medical questions
Can the rate of progression of Alzheimer’s disease be detected by a PET scan of the brain? Is mild to moderate disease characterized by difficulty performing cognitive tasks, frequent disorientation, delusions and short-term memory loss? Does an Alzheimer’s patient relive old experiences? Are promising Russian drugs undergoing FDA trials? Would someone be able to obtain an experimental drug without FDA approval? Can a patient live for years like this?
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The reality
“Alzheimer’s disease causes characteristic metabolic patterns of deficits which can be detected by PET scans,” says Dr. P. Murali Doraiswamy, chief of biological psychiatry at Duke University.
Initially, he says, the deficits are restricted to some concentrated areas in the parietal and temporal lobes, but as the dementia progresses, the deficits spread.
But Doraiswamy and William H. Thies, chief medical and scientific officer of the Alzheimer’s Assn., emphasize that PET scans are not definitive.
“No imaging technique is generally regarded as diagnostic for Alzheimer’s disease,” Thies says.
Experts vary in their reliance on scans to track disease progression, he adds.
The predominant symptoms of Alzheimer’s “vary a great deal from patient to patient,” Thies says, and it is possible for patients with mild- to moderate-stage disease to have the cognitive difficulties the show describes.
Typically, patients with early Alzheimer’s will lose new memories first; older memories become the patient’s frame of reference.
“Many patients have vivid memories of World War experiences but cannot recall what they ate for breakfast that morning,” Doraiswamy says.
But the scenario in which Crane actually relives past experiences with his daughter, as if he were physically back in time, is not quite realistic, Thies says.
Dimebon is a real antihistamine drug that has been studied for Alzheimer’s use in Russia. It is thought to have an effect on brain signaling chemicals and improving cellular energy in the brain.
A one-year Russian study on patients with mild to moderate Alzheimer’s presented in July at an Alzheimer’s meeting showed that Dimebon improved cognition, memory and activities of daily living.
The show accurately depicts that the drug is now in a Phase 3 clinical trial in the U.S. The drug rights belong to a company called Medivation, which has partnered with Pfizer to develop it, also as the show suggests.
People cannot generally access drugs under investigation unless they are participants in the clinical trials. Courts have repeatedly concluded that it is not in the public interest to allow regular access to experimental drugs as they don’t have proven effectiveness or safety. The courts also have ruled that you cannot force a company to make an unapproved drug available.
Doraiswamy says that persistent patients with life-threatening diseases can very occasionally get compassionate access to an experimental drug via an FDA compassionate use category wherein a patient is allowed to effectively become his or her own study.
This process, known as a single-patient Investigational New Drug, hasn’t occurred for Alzheimer’s treatments, Thies says. Sometimes too they can obtain a drug from a country where it is already approved.
Finally, Alzheimer’s disease does not always progress at the same rate. Doraiswamy and Thies say that patients with early Alzheimer’s can often live for several years (as many as 20) with mild, steady deterioration.
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